Pharmaceutical composition
Described herein is a pharmaceutical composition that includes a beta 2 -agonist selected from indacaterol and formoterol in combination with a corticosteroid selected from fluticasone and ciclesonide, and, optionally, one or more pharmaceutically acceptable excipients.
1. A pressurized metered dose inhaler comprising a pharmaceutical composition consisting of:
a) a beta2-agonist selected from indacaterol maleate in an amount ranging from 20-1200 mcg and formoterol fumarate present in an amount ranging from 0.5-40 mcg;
b) a corticosteroid selected from fluticasone furoate in an amount ranging from 0.5-800 mcg and ciclesonide in an amount ranging from 20-800 mcg; and
c) solubilizer selected from ethanol, PEG, glycerol, polyvinyl pyrrolidone or combination thereof; and
d) propellant
wherein the composition is in a form suitable for once daily administration, and
wherein the composition further consists of a cosolvent, an antioxidant, a surfactant, a bulking agent, and a lubricant.
2. A pressurized metered dose inhaler comprising a pharmaceutical composition according to claim 1 , wherein the corticosteroid is fluticasone furoate.
3. A pressurized metered dose inhaler comprising a pharmaceutical composition according to claim 1 , wherein the corticosteroid is ciclesonide.
4. A pressurized metered dose inhaler comprising a pharmaceutical composition of claim 1 , wherein the beta-2 agonist is indacaterol maleate and the corticosteroid is fluticasone furoate.
5. A pressurized metered dose inhaler comprising a pharmaceutical composition of claim 1 , wherein the beta-2 agonist is indacaterol maleate and the corticosteroid is ciclesonide.
6. A pressurized metered dose inhaler comprising a pharmaceutical composition according to claim 1 , wherein pharmaceutical composition along with any excipients are formulated in a single pharmaceutical composition.
7. A pressurized metered dose inhaler comprising a pharmaceutical composition according to claim 1 , wherein the bulking agent is a saccharide and/or a sugar alcohol.
8. A pressurized metered dose inhaler comprising a pharmaceutical composition according to claim 1 , further consisting of an excipient selected from a wetting agent, osmotic agent, a pH regulator, a buffering agent, and a complexing agent, provided in a pharmaceutically acceptable vehicle.
9. A method of treatment of a respiratory, inflammatory or obstructive airway disease, comprising administering a therapeutically effective amount of a pharmaceutical composition according to claim 1 to a patient in need thereof, wherein the disease is COPD or asthma.
10. A dry powder inhalation composition consisting of:
a) indacaterol maleate in an amount ranging from 20-1200 mcg or formoterol fumarate in an amount ranging from 0.5-40 mcg;
b) fluticasone furoate in an amount ranging from 0.5-800 mcg or ciclesonide in an amount ranging from 20-800 mcg;
c) lactose;
and, one or more pharmaceutically acceptable excipients selected from a propellant and a surfactant,
wherein the composition is in a form suitable for once daily administration.
11. A method of treatment of a respiratory, inflammatory or obstructive airway disease, comprising administering a therapeutically effective amount of a composition according to claim 10 to a patient in need thereof, wherein the disease is COPD or asthma.